Heart valve assembly and methods for using them

ABSTRACT

A heart valve assembly includes a base including a multi-lobular annular shape within a plane, a valve member or other annular body including a multi-lobular shape complementary to the shape of the base, and cooperating connectors on the base and the annular body for connecting the annular body to the base. The base includes an anchoring ring, and a flexible cuff for attaching the base to a biological annulus. The base and the annular body include guides for aligning their multi-lobular shapes, e.g., visual, tactile, or other markers, or tethers that extend from the base that are slidable through the annular body. During use, the base is attached to a biological annulus, the annular body is directed adjacent the annulus, oriented such that the multi-lobular shape of the annular body valve member is aligned with the base, and the annular body is attached to the base.

FIELD OF THE INVENTION

The present invention relates generally to heart valves that may beimplanted into a patient, and, more particularly, to multiple componentheart valve assemblies that may be assembled together, and to apparatusand methods for making and implanting them.

BACKGROUND

Prosthetic heart valves can replace defective human valves in patients.Prosthetic valves commonly include sewing rings, suture cuffs, or ringsthat are attached to and extend around the outer circumference of theprosthetic valve orifice. Because of their circular cross-sections,sewing rings that are implanted may not optimally fit the biologicalannulus into which a valve may be implanted. As a result, natural bloodhemodynamics through and around the valve may be impaired, resulting inclotting, possible emboli production, and eventual calcification of thevalve structure.

As patients grow, particularly pediatric patients, the leaflets of avalve may no longer be properly sized to fit the annulus. Leaflets mayalso calcify or otherwise foul and need to be replaced. To replace theleaflets on a single-piece prosthetic valve, the entire valve must beremoved, which may cause trauma to the annulus and jeopardizeimplantation of a replacement valve. Further, it may be difficult towork around and through leaflets of a valve to attach a leaflet-ladenvalve, possibly damaging the leaflets and extending the length of thevalve replacement procedure.

Sewing rings can also be tedious and time consuming to secure to a valveorifice. To assemble multiple component heart valves, one component hasto be sewn into another in vivo, resulting in a complex and timeconsuming process. The complexity of the procedure also provides agreater opportunity for mistakes and requires a patient to be oncardiopulmonary bypass for a lengthy period.

Multiple piece heart valves also typically require a significant amountof handling during implantation, potentially exposing the delicateleaflets to damage before or during in vivo implantation. Additionally,orientation of the components of a multiple piece heart valve isgenerally not defined by the device, making the implantation of thesecond piece of the valve less intuitive. The surgeon must align thecomponents of the valve during in vivo assembly when limited access canimpair dexterity and the fragile valve components are at risk of beingdamaged. Also, known multiple piece valves lack sufficient mechanicalsafeguards to insure that the surgeon will properly orient or secure thevalve components. Once implanted, multiple component heart valves canhave problems with the components fitting each other in a secure andstable manner. Improper fit can cause mechanical stress and hemodynamicanomalies leading to clotting, dislodgement or valve failure.

Accordingly, heart valves, particularly multiple piece valves that maybe reliably implanted into biological heart annuluses, e.g., to maximizehemodynamic flow and/or ease implantation, would be useful.

SUMMARY OF THE INVENTION

The present invention is directed to heart valves that may be implantedinto a patient, and, more particularly, to multiple component heartvalve assemblies that may be assembled together, and to apparatus andmethods for making and implanting them.

In accordance with one aspect of the present invention, a heart valveassembly is provided that includes a base member including amulti-lobular annular shape within a plane, an annular body including amulti-lobular shape complementary to the multi-lobular shape of the basemember, and cooperating connectors on the base member and the annularbody for connecting the annular body to the base member. In oneembodiment, the connectors may include mating detents on the base memberand annular body, e.g., one or more protrusions and one or moreapertures for receiving corresponding protrusions therein.

In an exemplary embodiment, the base member may include an anchoringring or other rigid base including one or more connectors thereon, and aflexible cuff for attaching the base to a biological annulus. Theflexible cuff may include a sewing ring extending radially from the baseand/or fabric or other material attached to and/or covering at least aportion of the base. In one embodiment, the base may include one or morewindows for accommodating a fastener, e.g., a clip or suture, forattaching the base to the annulus.

In addition or alternatively, the annular body may include a framecarrying one or more leaflets to provide a valve member. Alternatively,the annular body may be a connecting member for connecting a valvemember to the base member.

In accordance with another aspect of the present invention, a heartvalve assembly is provided that includes a base member generallydefining a plane and a longitudinal axis substantially orthogonal to theplane, the base member including a multi-lobular annular shape withinthe plane, an annular body including a multi-lobular shape complementaryto the multi-lobular shape of the base member, and guides on at leastone of the base member and the annular body for aligning themulti-lobular shapes with one another about the longitudinal axis.

Optionally, cooperating connectors may be provided on the base memberand the annular body for attaching the annular body to the base member.For example, the connectors may include mating detents on the basemember and the annular body, e.g., one or more protrusions and one ormore apertures for receiving corresponding protrusions therein.

In one embodiment, the guides may include visual markers on at least oneof the base member and the annular body that may aligned within oneanother when the multi-lobular shape of the annular body is aligned withthe multi-lobular shape of the base member. In addition oralternatively, the guides may include tactile or audio markers thatprovide an indication to a user that the annular body is aligned withthe base member. In another embodiment, the guides may include one ormore tethers extending from the base member through the annular bodysuch that the annular body is slidable along the tethers to align theannular body with the base member as the annular body is directedtowards the base member. Optionally, the tethers may include ratchetelements spaced apart along a portion of the tethers, thereby provided atactile indication as the annular body is directed towards the basemember, e.g., to identify a distance from the annular body to the basemember. Preferably, each tether extends through a port or other guidechannel in the annular body, and the ratchet elements may engage theguide channel to allow the annular body to be directed towards the baseelement but preventing the annular body from being directed away fromthe base member.

In accordance with yet another aspect of the present invention, a methodis provided for assembling a heart valve including a base memberincluding a multi-lobular annular shape and a second device including amulti-lobular shape complementary to the multi-lobular shape of the basemember. The second device may be moved adjacent to the base member,wherein the multi-lobular shape of the second device aligns with themulti-lobular shape of the base member, and the second device may thenbe attached to the base member. For example, the second device may beslid along one or more guide members towards the base member. Inaddition or alternatively, guides on the annular body and/or base membermay include visual, auditory, and/or tactile markers that may bemonitored to ensure that the annular body is aligned with the basemember.

Once the second device contacts or is otherwise adjacent the basemember, cooperating connectors on the second device and the base membermay engage to secure the second device to the base member. In oneembodiment, the second device may be a valve member, e.g., asingle-piece heart valve. Alternatively, the second device may be aframe or other annular body to which a valve may be attached eitherbefore or after attaching the frame to the base member. In thisalternative, guides may be provided to align and facilitate successiveattachment of each component to one another.

In accordance with still another aspect of the present invention, amethod is provided for implanting a heart valve within a biologicalannulus within a heart of a patient. Initially, a base member may beattached to the biological annulus, the base member having amulti-lobular annular shape corresponding generally to a cross-sectionof the annulus. A valve member including a multi-lobular shapecomplementary to the base member may be directed adjacent the annulus.The valve member may be oriented such that the multi-lobular shape ofthe valve member is aligned with the multi-lobular shape of the basemember, and the valve member may be attached to the base member.

Other objects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1 is an exploded perspective view of an embodiment of a heart valveassembly, including a base and a crown.

FIGS. 2-9 are cross-sectional views of various embodiments of the baseof FIG. 1, taken along section A-A, showing connectors thereon.

FIGS. 10 and 11 are perspective views of alternate embodiments of a basethat may be incorporated into a heart valve assembly.

FIGS. 12-18 are cross-sectional views of various embodiments of thecrown of FIG. 1, taken along section B-B, showing connectors thereon.

FIG. 19 is a cross-section of another embodiment of a heart valve,including a plurality of connectors on a base and crown that may ratchettogether.

FIG. 20 is a cross-sectional view of the base of FIG. 1, taken alongsection E-E.

FIG. 21 is a cross-sectional view of an alternative embodiment of a basethat may be incorporated into a heart valve assembly.

FIG. 22 is a cross-sectional view of the crown of FIG. 1, taken alongsection F-F.

FIG. 23 is a cross-sectional view of an alternative embodiment of acrown that may be connected to the base shown in FIG. 21 to provide aheart valve assembly.

FIGS. 24-26 are details of various embodiments of a guide channel thatmay be provided on a crown.

FIGS. 27-29 are perspective views of various embodiments of a guidemember.

FIG. 30 illustrates an embodiment of a valve holder, includingconnectors for releasably carrying a component of a heart valve assemblyduring implantation.

FIGS. 31-35 are cross-sectional views of a biological annulus, showing amethod for implanting a heart valve assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

1. Multiple-Component Heart Valve Assemblies

Turning to the drawings, FIG. 1 illustrates a heart valve assembly 10that generally includes a base member 12 and a valve member or “crown”14. As described further below, the base member 12 and/or crown 14 mayinclude one or more connectors for attaching the crown 14 to the base 12and/or one or more guides for facilitating aligning and/or connectingthe crown 14 with the base 12.

The base member 12 may be a generally annular shaped body lying in aplane 16, thereby defining a longitudinal axis 17 substantiallyorthogonal to the plane 16. The base member 12 may have a noncircularshape within the plane, such as a multi-lobular shape. Preferably, thebase member 12 has a tri-lobular shape, i.e., including three lobes 30separated by three cusps 28, corresponding generally to a cross-sectionof a biological annulus within which the base member 12 may beimplanted, as explained further below. It will be appreciated that thebase member 12 may define other noncircular shapes within the plane 16,e.g., that may correspond to anatomy of a patient within which the heartvalve assembly 10 may be implanted.

The base member 12 may include a substantially rigid anchoring ring orbase 18 and a flexible cuff or sewing ring 20 that may extend around aperiphery of the anchoring ring 18. The cuff 20 may simply be a layer offabric or other material covering at least a portion of the anchoringring 18. Alternatively, the cuff 20 may include a section of material(not shown) extending radially from the anchoring ring 18. The anchoringring 18 and cuff 20 may be integrally formed as a single element or maybe separate components attached to one another. In addition, the cuff 20may be slidably or fixedly attached to the anchoring ring 18.

The crown 14 may be a generally annular shaped body having anoncircular, e.g., multi-lobular shape, complementary to the base member12. Preferably, the crown 14 has a tri-lobular shape, similar to thebase member 12, including three lobes 40 separated by cusps 38. In apreferred embodiment, the crown 14 is a valve member including anannular frame 22, and a plurality of leaflets (not shown for clarity)extending from the frame 22, e.g., attached to commissures 23. The frame22 may include a plurality of struts (also not shown for clarity) thatmay be attached to and/or interact with the leaflets, similar to thestruts disclosed in U.S. Pat. No. 6,371,983, the entire disclosure ofwhich is expressly incorporated by reference herein. Alternatively, thecrown 14 may be a connecting device, such as the connection adapterelements shown in U.S. patent application Ser. No. 10/646,639, filed 22Aug. 2003, the entire disclosure of which is expressly incorporated byreference herein.

Components of the heart valve assembly 10, e.g., the base 18 and/orsewing ring 20 of the base member 12 and/or crown 14, may be made fromone or more materials, such as one or more alloys, such as alloys ofstainless steel, nickel titanium (“Nitinol”), cobalt-chrome (e.g.,ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® fromCarpenter Metals Corp., Wyomissing, Pa.), molybdenum (e.g., molybdenumTZM alloy, as disclosed, for example, in International Pub. No. WO03/082363 A2, published 9 Oct. 2003, which is herein incorporated byreference in its entirety), and/or tungsten-rhenium (e.g., as disclosedin International Pub. No. WO 03/082363). In addition or alternatively,the components may be made from polymers, such as polyester (e.g.,DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.),polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE),polyether ether ketone (PEEK), nylon, polyether-block co-polyamidepolymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyetherpolyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products,Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane,thermoplastic, fluorinated ethylene propylene (FEP). In addition oralternatively, the components may be from or include other materials,such ass extruded collagen, silicone, echogenic, radioactive, radiopaquematerial or combinations thereof. Exemplary radiopaque materials thatmay be used include barium sulfate, titanium, stainless steel,nickel-titanium alloys, tantalum, and/or gold.

Any or all elements of the heart valve assembly 10, for example, thecuff 20, may include a matrix for cell ingrowth, a fabric, or otherflexible material, e.g., a covering (not shown) that may act as a matrixfor cell ingrowth, and/or that may be penetrated with a fastener used toattach the cuff 20 to an annulus within which the heart valve assembly10 is implanted. Exemplary fabric material may include polyester (e.g.,DACRON® from E. I. du Pont de Nemours and Company, Wilmington, Del.),polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone, and/orcombinations thereof. Optionally, the cuff 20 may be an o-ring, or mayinclude a cushioned material, double velour material, and the like,attached using glue or other adhesives and/or fasteners.

Optionally, the heart valve assembly 10 and/or any fabric therein mayalso be filled and/or coated with one or more agent delivery matricesknown to those skilled in the art, a therapeutic agent, and/or adiagnostic agent. These agents may include radioactive materials;radiopaque materials; cytogenic agents; cytotoxic agents; cytostaticagents; thrombogenic agents, for example, polyurethane, celluloseacetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol;lubricious, hydrophilic materials; phosphor cholene; anti-inflammatoryagents, for example, non-steroidal anti-inflammatories (NSAIDs), such ascyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, forexample ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, forexample ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamicacid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., WhitehouseStation, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1inhibitors); immunosuppressive agents, for example, Sirolimus(RAPAMUNE®, from Wyeth, , Collegeville, Pa.), or matrixmetalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracyclinederivatives) that act early within the pathways of an inflammatoryresponse. Examples of other agents that may be used are disclosed inWalton et al, Inhibition of Prostoglandin E₂ Synthesis in AbdominalAortic Aneurysms, Circulation, Jul. 6, 1999, 48-54; Tambiah et al,Provocation of Experimental Aortic Inflammation Mediators and ChlamydiaPneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al, Uptake ofTetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation andProteolysis, Brit. J. Surgery 86 (6), 771-775; Xu et al, Sp1 IncreasesExpression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium, J.Biological Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted GeneDisruption of Matrix Metalloproteinase-9 (Gelatinase B) SuppressesDevelopment of Experimental Abdominal Aortic Aneurysms, J. ClinicalInvestigation 105 (11), 1641-1649. The entire disclosures of thesereferences and any others cited therein are expressly incorporated byreference herein.

The base member 12 and the crown 14 may include cooperating detents orother connectors for attaching the crown 14 to the base member 12.Turning to FIGS. 2-9, the base member 12 may include protrusions 24,e.g., tabs or prongs, extending from at least one of the anchoring ring18 and the cuff 20. The protrusions 24 may be separate from or integralwith the cuff 20 and/or anchoring ring 18. In an exemplary embodiment,shown in FIG. 2, the protrusions 24 extend from the anchoring ring 18such that they define a sloping proximal surface 24 a to accommodatesliding along the crown 14 (not shown) and a blunt distal surface 24 bfor interlocking with the crown 14 to prevent separation of the crown 14from the base member 12. The protrusions 24 may be resilient, e.g., maybe biased to extend in a desired direction, e.g., substantially parallelor transverse to the longitudinal axis 17, yet may be resilientlycompressed or deflected to facilitate connection of the crown 14 to thebase member 12.

For example, as shown in FIGS. 1 and 20, a plurality of protrusions 24may be provided on the anchoring ring 18, e.g., spaced apart from oneanother about a periphery of the base member 12. In a preferredembodiment, the base member 12 has three sets of protrusions 24, e.g.,one set disposed in each lobe 26, offset from one another approximately120° about the longitudinal axis 17. As shown in FIG. 20, theprotrusions 24 may be located along an inner surface at the cusps 28 ofthe base member 12, although alternatively, the protrusions may beprovided at the outer apices and/or along inner edges of the lobes 30,such as along the outer edges of the lobes 30, as shown in FIG. 21.

FIG. 3 shows an alternative embodiment of a protrusion 24,′ namely aflange extending from the anchoring ring 18.′ The protrusion 24′ may bebiased such that a free end 24 b′ of the flanges extends diagonally awayfrom the anchoring ring 18′, thereby defining a sloped proximal surface24 a.′ The protrusion 24′ may be caused to deflect against or into thewall of the anchoring ring 18′ but may resiliently return outwardly oncereleased, e.g., such that the free end 24 b′ is received in an apertureof a crown 14′ (not shown, see, e.g., FIG. 13) to secure the crown 14′to the anchoring ring 18.′ FIG. 4 illustrates another alternativeembodiment of a protrusion 24″ that includes a blunt distal surface 24b″and a proximal free end 24 a″ that may be biased outwardly yetcollapsible, similar to the embodiment of FIG. 2. FIG. 5 illustratesstill another embodiment of a protrusion 24′″ with a free end unattachedto an anchoring ring 18.′″ In addition or alternatively, as shown inFIG. 6, a protrusion 24″″ may be provided that is solid, and may befilled with a material, such as the radiopaque or other materialsdescribed above and/or an agent delivery matrix, therapeutic agent,and/or diagnostic agent, also as described above.

Turning to FIG. 7, another embodiment of a connector 124 is shown thatmay be provided on an anchoring ring 118 (or other component of a basemember 112). The connector 124 includes a plurality of detents 125(e.g., four shown) spaced apart axially from one another along adirection of the longitudinal axis 117.

Turning to FIG. 8, another embodiment of an anchoring ring 218 us shownthat has a shape that tapers axially relative to longitudinal axis 217.In the embodiment shown, the anchoring ring 218 includes an innersurface that defines an angle 219 with respect to the longitudinal axis217. A protrusion 224 extends from the inner surface of the anchoringring 218 that includes a sloped proximal surface 224 a and a bluntdistal surface 224 b, similar to previous embodiments. Alternatively,the protrusion 224 may extend from the outer surface or other location(not shown) of the anchoring ring 218.

FIG. 9 illustrates another alternative embodiment of an anchoring ring218″ that includes a plurality of protrusions 224″ (e.g., sixteen shown)that are spaced apart from one another along a direction defining anangle 219″ with the longitudinal axis 217″ to provide a ratchetingconnector.

Turning to FIG. 10, another embodiment of a base member 312 is shownthat includes a plurality of protrusions 324 on legs 313 extending fromthe base member 312 in a direction substantially parallel to alongitudinal axis 317. The legs 313 may be integrally formed with thebase member 312 or may be attached to the base member 312, and mayextend proximally or distally (not shown) from the base member 312.

Turning to FIG. 11, another embodiment of a base member 412 is shownthat includes connectors, i.e., tabs or protrusions 424 e located on anouter surface of the base member 412, i.e., from the anchoring ring 418or the cuff 420 thereof. Preferably, the cuff 420 is shaped and/or isattached to the anchoring ring 418 to ensure that the protrusions 424are exposed to be engaged with mating connectors on a crown (not shown)attached to the base member 412.

Returning to FIG. 1, optionally, the anchoring ring 18 may include oneor more base attachment windows 32, e.g., formed in the lobes 30. Thewindows 32 may extend radially through the anchoring rings 18 toaccommodate fasteners (not shown) being inserted therethrough. Forexample, if cuff 20 covers the base attachment windows 32, a clip orsuture (not shown) may be inserted into the window 32 from the inside,through the cuff 20 and into surrounding tissue to attach the basemember 12 to the tissue, as explained more particularly below. Exemplaryfasteners and methods for implanting heart valves or devices usingfasteners are disclosed in U.S. application Ser. No. 10/681,700, filedOct. 8, 2003, and entitled “Attachment Device and Methods of Using theSame.” The entire disclosure of this reference and any references citedtherein are expressly incorporated herein by reference.

Similarly, the crown 14 may include one or more crown attachment windows36, which may be openings or recesses in the wall or frame of the crown14, preferably extending completely through the wall of the crown 14.The crown attachment windows 36 may be provided in the lobes 40 suchthat they are aligned with the base attachment windows 32 in the basemember 12 when the crown 14 is attached to the base member 12.

Turning to FIG. 12, the crown 14 may include one or more cooperatingconnectors that may interact with the connectors on the base member 12to secure the crown 14 to the base member 12. For example, as shown, aplurality of apertures 34, e.g., holes, slots, pockets, cavities, andthe like, may be provided in the crown 14 for receiving the protrusions24 therein. The material adjacent the apertures 34 may be sufficientlyflexible and/or resilient to yield and allow the protrusions 24 to bereceived therein. The apertures 34 may have a variety of shapescorresponding to the shapes of the protrusions 24, e.g., square,rectangular, circular, or oval shape.

Alternatively, protrusions (not shown) may be provided on the crown 14instead of or in addition to the apertures 34, each including a slopingdistal surface and a blunt proximal surface. The sloping edge of aprotrusion on the crown 14 may slide along the sloping edge of acorresponding protrusion on the base member 12 until the blunt edgesinterlock to secure the crown 14 relative to the base member 12.Optionally, at least one of the base member 12 and the crown 14 mayinclude a track or channel adjacent the protrusions for guiding theprotrusions on the crown 14 into alignment with the protrusions on thebase member 12.

Turning to FIGS. 13-18, alternative embodiments of crowns are shown thatinclude apertures that may be used to received connectors from basemembers, such as those shown in FIGS. 3-9. Optionally, a covering (notshown) may be attached to or otherwise surround the crowns, as long asthe apertures are exposed to receive the mating connectors from the basemembers.

FIG. 13 illustrates an embodiment of a crown 14′ that includes a taperedsection 15′ angled relative to the longitudinal axis 17′ and an aperture34.′ In this embodiment, the base member 12′ (not shown) may include acomplementary taper such that crown 14′ may fit into or over, and,consequently, mate with the base member 12.′

Turning to FIG. 14, another embodiment of a crown 114 is shown thatincludes a connector including a plurality of apertures 134 (four shown)spaced apart axially from one another along a direction of alongitudinal axis 117. Apertures 134 may be provided at the distaland/or proximal (not shown) ends of the crown 114 such that theapertures 134 may receive corresponding protrusions 125 from the basemember 112 (not shown, see FIG. 7).

FIG. 15 shows another alternative embodiment of a crown 114′ thatincludes multiple apertures 134,″ each having an adjacent wall sectionthat is angled relative to the longitudinal axis 217.′ These angled orramped wall sections may facilitate protrusions on a base member (notshown) being received therein when the crown 114′ is being connected tothe base member.

FIG. 16 shows yet another embodiment of a crown 214 having a taperedshape defining an angle 221 that is complementary to the base member 212shown in FIG. 8. The crown 214 includes an aperture 234 in the innersurface, although the aperture 234 may be provided at other locationscorresponding to the protrusion 224 on the base member 212.

Turning to FIGS. 17-19, additional embodiments of crowns 214,′ 214″ areshown that have a tapered shape, and include a plurality of detents234,′ 234″ (fifteen shown) for interlocking with cooperating detents424″ on base member 212″ (shown in FIGS. 9 and 19). In the embodimentshown in FIG. 17, apertures 234′ extend completely through a wall of thecrown 214.′ Alternatively, as shown in FIG. 18, the crown 214″ mayinclude apertures 234″ that do not extend completely through a wall ofthe crown 214,″ thereby defining pockets.

As shown in FIG. 19, the crown 214″ and the base member 212″ includecomplementary tapered shapes, e.g., tapering from a larger distaldimension to a smaller proximal dimension. In this embodiment, thedetents 234″ are on the inner surface of the crown 214″ and the detents224″ are on the outer surface of the base member 212.″ Thus, when thecrown 214″ is directed over the base member 212,″ at least a portion ofthe base member 212″ is received in the crown 214″ such that the detents234,″ 224″ ratchet together. The cooperating detents 224,″ 234″ mayinterlock when the crown 214″ is directed against the base member 212,″thereby attaching the crown 214″ to the base member 212.″

Alternatively, the crown and base member may be tapered smaller fromtheir proximal to distal ends (not shown). In this alternative, thedetents may be provided on an outer surface of the crown and on an innersurface of the base member to allow the detents to ratchet together. Itwill be appreciated that the crown 214″ and base member 212″ shown inFIG. 19 are not to scale. Preferably, the slope of the taper is suchthat the length of the crown 214″ and base member 212″ is longer thanthe change in their cross-sections, thereby maximizing the openingthrough the crown 214″ and base member 212,″ e.g., to maximizehemodynamic flow through the resulting heart valve assembly 210.″

During assembly, when a crown, such as the crown 14 shown in FIGS. 1 and22 is rotated about the longitudinal axis 17 relative to a base member12, such as that shown in FIGS. 1 and 20, the lobes 40 of the crown 14may be aligned with the lobes 30 of the base member 12. When the crown14 is then placed against the base member 12, the protrusions 24 andapertures 34 may be aligned with one another such that the protrusions24 may be received in corresponding apertures 34 to attach the crown 14to the base member 12.

Although the exemplary embodiment shown in FIG. 1 shows protrusions 24provided on the base member 12 and corresponding apertures 34 areprovided on the crown 14, it will be appreciated that the protrusionsand apertures may be interchanged on the base member 12 and crown 14(not shown). As long as each protrusion on one of the base member andcrown can be aligned with a corresponding aperture or protrusion on theother of the crown and the base member, cooperating connectors may beused to attach the crown to the base member.

Returning to FIG. 1, in addition or alternatively to the cooperatingconnectors described above, the base member 12 and/or crown 14 mayinclude one or more guide markers for facilitating aligning the crown 14with the base member 12. For example, the base member 12 and crown 14may include a set of one or more guide markers 42, 44 that may beraised, textured, colored, radiopaque, and/or echogenic markers on asurface of the base member 122 and/or crown 14. The guide markers mayprovide a visual indication (e.g., directly and/or using an imagingapparatus), an auditory indication, and/or a tactile indication of therelative orientation and/or location of the crown 14 with the basemember 12, e.g., about the longitudinal axis 17.

For example, as shown in FIG. 1, visual guide markers 42, 44 may beprovided on the crown 14 and the base member 12, e.g., at one or more ofthe cusps 38, 28. As shown, the markers 42 are provided on an outersurface of the crown 14 and on a proximal surface of the base member122. Alternatively or in addition, guide markers (not shown) may beprovided on the lobes 40, 30, and/or on inner surfaces, proximalsurfaces, and/or distal surfaces of the crown 14 and/or the base member12. Thus, the visual markers 42 on the crown 14 may align with themarkers 44 on the base member 12 when the crown 14 is aligned with thebase member 12. A user observing the crown 14 being directed towards thebase member 12, e.g., from above, may be informed that the crown 14 isproperly oriented and/or may be properly connected to the base member 12based upon the visual markers 42, 44. Optionally, the visual markers 42,44 may include symbols, e.g., triangles, circles, rectangles, and thelike (not shown), that may be easily identified, e.g., to inform asurgeon of the location on the crown 14 and/or base member 12 associatedwith a particular symbol.

In addition or alternatively, tactile markers, such as tab markers 46may be provided on the base member 12 and/or, optionally, on the crown14. As shown in FIG. 1, the tab markers 46 are raised portions extendingfrom the upper or proximal surface of the anchoring ring 18 at the cusps28. To form the tab markers 46, a height of the anchoring ring 18(parallel to the longitudinal axis 17) may be varied, e.g., making theheight smaller at the lobes 30 and larger at the cusps 28 thin such thatportions of the anchoring ring 18 at the cusps 28 extend proximally,thereby defining the tab markers 46. Stated differently, the proximalsurface of the anchoring ring 18 may have a scalloped shape, e.g., wherethe height of the anchoring ring 18 peaks at the cusps 28 and definesvalleys at the lobes 30.

In order to mate with the base member 12, the distal surface of thecrown 14 may have a complementary shape. For example, the cusps 38 ofthe crown 14 may have a smaller height than the lobes 40 such that thetab markers 46 may be received in recesses (not shown) in the crown 14.Thus, when the crown 14 is oriented about the longitudinal axis 17relative to the base member 12, the complementary shapes of the basemember 12 and crown 14 may only permit the crown 14 to be mated with thebase member 12 when the complementary shapes, e.g., the tab markers 46and recesses, fit together. Thus, the user may receive a tactileindication when the crown 14 is be aligned with the base member 12 inorder to ensure that the multi-lobular shapes of the crown 14 and basemember 12 are aligned before connecting them together.

In addition or alternatively, the guides may include one or moreelongate guide members 50, e.g., including depth markers 52 and/orunidirectional or bidirectional retention elements, e.g., ratchetingelements 54. As explained further elsewhere herein, these guide membersmay also provided connectors for attaching the crown 14 to the basemember 12. The guide members 50 may be threads, filaments, wires, orother tethers that extend from the base member 12. The tethers 50 may beattached to, pre-threaded through, or otherwise placed on the basemember 12, e.g., at spaced apart intervals, preferably at the ends ofthe lobes 30 such that tethers 50 may be aligned with the commissures 23on the crown 14. For example, the tethers 50 may be attached to the basemember 12 during manufacturing or before or during implantation of theheart valve assembly 10.

The tethers 50 may be formed from a variety of materials, similar toother components of the heart valve assembly 10, as described elsewhereherein, e.g., a fine gauge wire or suture material. The tethers 50 maybe stiff or flexible, and/or may be resiliently bendable or plasticallypliable. In addition, the tethers 50 may have a variety ofcross-sections. For example, FIG. 27 shows a guide member 50′ having asquare or rectangular cross-sectional shape, FIG. 28 shows a guidemember 50″ having a circular or oval cross-sectional shape, and FIG. 29shows a guide member 50′″ having a semi-circular or semi-ovalcross-sectional shape.

Optionally a guide tube (not shown) may be provided through which eachtether 50 may be inserted. The guide tube may be a substantially rigid,semi-rigid, or flexible tubular body, e.g., a hypotube or polyamidetube. Such guide tubes may enhance the column strength of the tethersduring their use to guide a crown towards a base member. The guide tubesmay be slidable relative to the tethers such that guide tubes may beremoved proximally from around the tethers during a procedure, asexplained further below.

Turning to FIGS. 24-26, the crown 14 may include one or more ports orguide channels through which guide member, such as the tethers 50 shownin FIG. 1, may be introduced. For example, as shown in FIG. 24, a guidechannel 56 is shown that may be formed in a wall of the crown 14. In theembodiment shown, a recess 57 may be provided in the crown 14, e.g., inan outer surface (shown) or an inner surface (not shown) thereof, thatextends axially along the crown 14. A cover 58 may extend across atleast a portion of the recession 57, thereby defining the guide channel56 thereunder. A guide member, such as tether 50 described above (notshown), may be inserted through the guide channel 56, e.g., in thedirection shown by arrows 59. The guide channel 56 may have a variety ofcross-sections, e.g., a rectangular cross-section, as shown, oralternatively, a square, semi-circular or other at least partialelliptical shape (not shown), depending upon the shape of the tether 50.If a guide tube is provided around the tether, the guide channel 56 mayhave a size large enough to slidably receive the guide tubetherethrough.

Turning to FIG. 25, an alternative embodiment of a guide channel 56′ isshown that may be formed by and/or in a wall of the crown 14.° Forexample, transverse slots 57′ may be created in the wall of the crown14′ at two locations axially disposed from one another, thereby creatinga guide channel 56′ under the wall 58′ through the openings 57.′Alternatively, a separate piece of material may be attached to the wallof the crown 14′ to create the guide channel 56.′

Turning to FIG. 26, yet another embodiment of a guide channel 56″ isshown extending from a crown 14.″ In this embodiment, the guide channel56″ may be a tubular section of material 58″ attached to the wall of thecrown 14,″ e.g., by an adhesive, sutures, and the like. The guidechannel 56″ may have a cylindrical shape, as shown, or other shapes (notshown). Optionally, the guide channels may include a guide tube therein,e.g., similar to the guide tubes described above for reinforcing thetethers 50.

Returning to FIG. 1, when tethers 50 (or other guide members, not shown)are inserted through guide channels (not shown) at correspondinglocations in the crown 14, the crown 14 may be slidable along thetethers 50. Thus, the crown 14 may be lowered towards the base member 12along the tethers 50. Preferably, the tethers 50 and corresponding guidechannels are attached at the ends of the lobes 30, 40 of the base member12 and crown 14.

Once the crown 14 is lowered to meet the base member 12, the tethers 50may be tightened or deployed to attach the crown 14 to the base member12. The tethers may be used in conjunction with other connectorsdescribed herein, e.g., to form a redundant connection, or may be usedalone to form both the connection between the crown 14 and the basemember 12, while also acting as a guide to orient the devices.

To facilitate guiding the crown 14, the tethers 50 may includeratcheting elements 54, e.g., pawls or other detents, that may interactwith the crown 14 and/or the guide channels. The ratcheting elements 54may provide a tactile indicator of the distance from the crown 14 to thebase member 12 and/or may prevent the crown 14 from being removed onceit is directed towards the base member 12. For example, the ratchetingelements 54 may include sloping proximal surfaces and blunt distalsurfaces, allowing the crown 14 to be directed down the tethers 50, butpreventing them from being directed back up. Alternatively, theratcheting elements 54 may including sloping proximal and distalsurfaces, allowing the crown 14 to be directed down or up the tethers50, but provided a resistance to movement.

In addition, the ratcheting elements 54 may include one or more sets ofdetents spaced apart at different distances along the tethers 50. Forexample, a first set of detents (not shown) may be provided at apredetermined distance from the base member 12, e.g., severalcentimeters. When the crown 14 contacts the first set of detents, theuser may hear or feel the detents, thereby providing a tactile orauditory indication of the distance from the crown 14 to the base member12. A second set of detents (also not shown) may then be provided toindicate that the crown 14 has been lowered into its final positionseated against the base member 12. Optionally, additional intermediatesets of detents may be provided spaced apart between the first andsecond sets, thereby providing a depth gauge that may inform the userhow far the crown 14 has been lowered or has left to be lowered.

In addition or alternatively, the detents may vary in size along thelength of the tethers. For example, larger detents may be provided atpredetermined intervals (not shown), provided greater auditory and/ortactile feedback to the user. In alternative embodiments, the detentsmay decrease in size from the ends of the tethers 50 towards the basemember 12, may increase in size towards the base member 12, or may varyin some other desired manner, depending upon the feedback intended to beprovided to the user.

Methods for Making Heart Valve Assembles

The components of the heart valve assemblies described herein may bemanufactured using methods well known to those skilled in the art. Forexample, manufacturing techniques that may be used include molding,machining, casting, forming (e.g., pressure forming), crimping,stamping, melting, screwing, gluing, welding, die cutting, lasercutting, electrical discharge machining (EDM), etching or combinationsthereof.

Heart valve assemblies disclosed in U.S. Pat. Nos. 6,241,765, 6,371,983,and 5,976,183 may be modified such that they may incorporated into acrown or may be attached to a valve connector adaptor, such as thosedescribed herein. The entire disclosures of these references and anyothers cited therein are expressly incorporated herein by reference.Other heart valves that may be incorporated into a heart valve assembly,as described herein, may include, for example, the Advantage Bileafletheart valve, Parallel valve, Freestyle stentless aortic valve, HancockPorcine heart valve, Hancock apical left ventricular connector model174A, Hancock valved conduit models 100, 105, 150, Hall Medtronic heartvalve, Hall Medtronic valved conduit, MOSAIC® heart valve, Intactporcine tissue valve (by Medtronic, Inc. Minneapolis, Minn.), AngeliniLamina-flo valve (by Cardio Carbon Company, Ltd., England), Bjork-Shileysingle-disk, monostrut and caged-disk valves (Shiley, Inc., now-defunct,previously of California), Wada-Cutter valve and Chitra Cooley-Cuttervalve (by Cutter Biomedical Corp., San Diego, Calif.), Angioflextrileaflet polyurethane valve (by Abiomed, Inc., Danvers, Mass.), ATS APSeries heart valve and ATS Standard heart valve (by ATS Medical, Inc.,Minneapolis, Minn.), ANNULOFLO® annuloplasty ring, ANNUFLEX®annuloplasty ring, CARBSEAL® valved conduit, ORBIS® Universal aortic andmitral valve, pediatric/small adult valve, R series valve, SUMIT® mitralvalve, TOP HAT® aortic valve, OPTIFORM® mitral valve, MITROFLOW SYNERGY®PC stented aortic pericardial bioprosthesis, the SYNERGY® ST stentedaortic and mitral porcine bioprosthesis (by CarboMedics, Inc., Austin,Tex.), ON-X® prosthetic heart valve (by MCRI®, LLC, Austin, Tex.),Starr-Edwards SILASTIC® ball valve, Starr-Edwards 1000, Starr-Edwards1200, Starr-Edwards 1260, Starr-Edwards 2400, Starr-Edwards 6300,Starr-Edwards 6500, Starr-Edwards 6520, Carpentier-Edwards porcinetissue valve, Carpentier-Edwards pericardial prosthesis,Carpentier-Edwards supra-annular valve, Carpentier-Edwards annuloplastyrings, Duromedics valve and PERIMOUNT® heart valve (by EdwardsLifesciences Corp., Irvine, Calif.); Cross-Jones Lenticular disc valve(by Pemco, Inc.), Tissuemed stented porcine valve (by Tissuemed, Ltd.,Leeds, England), Tekna valve (by Baxter Healthcare, Corp., Deerfield,Ill.), Komp-01 mitral retainer ring (by Jyros Medical Ltd., London,England), SJM® Masters Series mechanical heart valve, SJM® MastersSeries aortic valved graft prosthesis, ST. JUDE MEDICAL® mechanicalheart valves, ST. JUDE MEDICAL® mechanical heart valve Hemodynamic Plus(HP) series, SJM REGENT® valve, TORONTO SPV® (Stentless Porcine Valve)valve, SJM BIOCOR® valve, SJM EPICS valve (St. Jude Medical, Inc., St.Paul, Minn.), and Sorin Bicarbon, Sorin Carbocast, Sorin CarbosealConduit, Sorin Pericarbon and Sorin Pericarbon Stentless (by SniaS.p.A., Italy).

Any elements, sub-assemblies, or the entire heart valve assembliesdescribed herein may be coated, e.g., by dip-coating or spray-coatingmethods known to one having ordinary skill in the art, utilizingmaterials such as PTFE (e.g., TEFLON® from E. I. du Pont de Nemours andCompany, Wilmington, Del.), polyester (e.g., DACRON® from E. I. du Pontde Nemours and Company, Wilmington, Del.), gelatin, gel, other polymersor combinations thereof. One example of a method used to coat a medicaldevice for vascular use is provided in U.S. Pat. No. 6,358,556 by Dinget al. The entire disclosure of this reference is incorporated herein byreference. Time release coating methods known to one having ordinaryskill in the art may also be used to delay the release of an agent inthe coating. The coatings may be thrombogenic or anti-thrombogenic.

The heart valve assemblies or any elements thereof (e.g., the basemember) may be covered with a fabric, for example, polyester (e.g.,DACRON® from E. I. du Pont de Nemours and Company, Wilmington, Del.),polypropylene, PTFE (e.g., TEFLON® from E. I. du Pont de Nemours andCompany, Wilmington, Del.), ePTFE, nylon, extruded collagen, gel,gelatin, silicone, or combinations thereof. Methods of covering animplantable device with fabric are known to those having ordinary skillin the art, for example, sintering, spray coating, adhesion, loosecovering, dipping, or combinations thereof.

Methods for Implanting Heart Valve Assemblies

Turning to FIG. 30, an exemplary embodiment of a tool is shown, namely avalve driver or holder 60. generally, the holder 60 may include anelongate shaft 62 including a handle 64 on a proximal end 66 and aplurality of arms 68 on a distal end 70 thereof. The shaft 62 may be asubstantially rigid and/or malleable body that may be fixed or rotatablerelative to the arms 68. Free ends 72 of the arms 68 may includeconnectors 74 that may be configured for releasably holding a basemember and/or crown (not shown), such as those described above. Althoughthree arms 68 are shown, it will be appreciated that more or fewer armsmay be provided (not shown), if desired. The connectors 74 may beremotely triggered, e.g., from an actuator (not shown) on the handle 64,to attach and/or release a base and/or crown. FIG. 33 shows the holder60 carrying a crown 12 using the connectors 74 on arms 68.

Turning to FIGS. 31-35, a method is shown for implanting a heart valveassembly within a biological annulus 90, which may be the site forreplacement of an existing natural or previously implanted heart valve,such as a tricuspid, mitral, aortic, or pulmonary valve within apatient's heart (not shown). The annulus 90 may have multiple, forexample two or three natural lobes 92 (three lobes being shown in FIG.31 with one lobe cut-away). Although the method described below refersgenerally the heart valve assembly 10 shown in FIG. 1, it will beappreciated that any of the components described herein may be implantedusing similar procedures.

Before implanting the heart valve assembly 10, the patient may beprepared for the procedure using known methods. For example, the patientmay be placed on cardiopulmonary bypass (CPB), and the patient's heartmay be exposed, e.g., by sternotomy, thoracotomy, or other open orminimally invasive procedure. An incision may be created in the bloodvessel above the valve being replaced (not shown), e.g., the aorta foran aortic valve replacement, in order to access the annulus 90. Theexisting natural or prosthetic heart valve (also not shown) may beremoved from the annulus 90 using known methods. A base member 12 may beselected based upon the anatomy encountered, e.g., having a plurality oflobes 30 matching the lobes 92 of the annulus 90 and/or having across-sectional dimension corresponding to the interior cross-section ofthe annulus 90.

As shown in FIG. 31 the base member 12 may be introduced into theannulus 90, as shown by arrows 94. The base member 10 may be carriedinto the annulus 90 using the holder 60 (not shown) or other tool. Ifnecessary, based upon the anatomy encountered, the shaft 62 of theholder 60 may be bent or otherwise deformed to facilitate accuratelyplacing the base member 12 within the annulus 90. The base member 12 mayoriented before or while being introduced into the annulus 90 such thatthe lobes 30 of the base member 12 are aligned with the natural lobes 92of the annulus 90. Once properly oriented, the base member 12 be securedwithin the annulus 90, whereupon the base member 12 may be released fromthe holder 60, which may then be removed from the annulus 90.

As shown in FIG. 32, the base member 12 is implanted directly within theannulus 90. For example, one or more fasteners 96, e.g., clips orsutures (not shown), may be directed through the base attachment windows32 into tissue 98 surrounding the annulus 90. For example, a pluralityof fasteners (not shown) may be driven through a flexible cuff 20surrounding an anchoring ring 18 having the windows 32 therein, e.g.,spaced apart from one another about the periphery of the base member 12.Exemplary fasteners and methods for using them to implant the basemember 12 may be found in U.S. patent application Ser. Nos. 10/327,821,filed 20 Dec. 2002, Ser. No. 10/646,639, filed 22 Aug. 2003, and Ser.No. 10/681,700, filed 8 Oct. 2003, the entire disclosures of which areincorporated by reference herein.

Alternatively, the base member 12 may be implanted above the biologicalannulus 90, e.g., within the enlarged space above a natural valveannulus. This configuration may allow a larger heart valve assembly 10to be implanted, thereby maximizing the open area through which bloodmay flow through the implantation site. In this configuration, the basemember 12 may include a flexible sewing ring (not shown) that may beplaced against the tissue above the annulus 90, whereupon one or morefasteners may be driven through the sewing ring into the tissue tosecure the base member 12.

As shown in FIGS. 31 and 32, the tethers 50 or other guide members maybe attached to the base member 12 when the base member 12 is introducedinto the annulus 90. For example, the tethers 50 may be attached to thebase member 12 during manufacturing or in preparation for performing thevalve implantation procedure. Alternatively, the tethers 50 may beattached to the base member 12 after being deployed in the annulus 90,e.g., by threading the tethers 50 through openings in the base member12. Preferably, the tethers 50 extend from the outer ends of the lobes30 of the base member 12, although alternatively, the tethers 50 mayextend from the cusps 28 or other locations (not shown). In addition,the tethers 50 may extend through a

Turning to FIG. 33, the crown 14 may be introduced into the annulus 90,e.g., using the holder 60. In one embodiment, the leaflets (not shown)may be attached to the crown 14 before the crown 14 is introduced. Ifthe base member 12 includes tethers 50 or other guide members, thetethers 50 may be fed through guide channels (not shown) in the crown14. If tubular guides (not shown) are provided around the tethers 50,the tubular guides may be fed through the guide channels, which mayinclude their own tubular guides. Once the tethers 50 are insertedthrough the guide channels, the tubular guides may be removed or mayremain to facilitate manipulation of the tethers 50.

The tethers 50 may facilitate aligning the crown 14 with the base member12, e.g., radially about longitudinal axis 17. The ratcheting elements54 on the tethers 50 may provide audible and/or tactile feedback to theuser as the crown 14 is advanced down the tethers 50 towards the basemember 12. In addition or alternatively, visual markers on the crown 14and/or base member 12, e.g., markers 42, 44 may be monitored directly orvia imaging (e.g., x-ray, magnetic resonance imaging (MRI), ultrasound,computed tomography (CT), echocardiogram, and the like), providingfeedback regarding the proximity and orientation of the crown 14relative to the base member 12. In addition or alternatively, theprotrusion guide markers 46 may provide tactile feedback of theproximity and orientation of the crown 14.

As shown in FIG. 34, once the crown 14 is oriented and guided into itsproper orientation relative to the base member 12, the crown 14 may bedeployed and attached to the base member 12. As shown, as the crown 14is placed adjacent the base member 12, the crown 14 may at leastpartially enter the base member 12. Alternatively, the crown 14 may atleast partially surround the base member 12 or merely abut the basemember 12 (not shown). As the crown 14 is seated against the base member12, cooperating connectors 34, 24 on the crown 14 and base member 12 mayengage one another to substantially secure the crown 14 to the basemember 12. For example, as described above, protrusions 24 on the basemember 12 may engage within apertures 34 in the crown 14. The connectors34, 24 may removably or substantially permanently attach the crown 14 tothe base member 12. As the protrusions 24 enter into the apertures 34,they may provide audible and/or tactile feedback to the user regardingthe proper placement and attachment of the crown 14 and the base member12.

In addition or alternatively, the tethers 50 may include ratchetingelements (not shown) that engage when the crown 14 is seated against thebase member 12. For example, these ratcheting elements may interlockwith the guide channels of the crown 14, thereby preventing the crown 14from being removed from the base member 12. The tethers 50 may then becut or otherwise disconnected above the crown 14, thereby providingconnectors securing the crown 14 to the base member 12. Optionally, thetethers 50 may be knotted to further secure the crown 14 and/or may bewelded or fused, e.g., using radio frequency (RF) energy, an adhesive,and the like. Alternatively, if the tethers 50 are removable from thebase member 12, the tethers 50 may be removed after the cooperatingconnectors 42, 44 engage, e.g., by releasing one end of a looped threaddefining each tether, and pulling the thread completely out of the basemember 12 and crown 14.

Once the crown 14 is secured to the base member 12, the crown 14 may bereleased from the holder 60, e.g., by releasing connectors 74, expandingarms 68, and the like, and the holder 60 may be removed. FIG. 35illustrates the heart valve assembly 10 once the crown 14 and basemember 12 are properly deployed in the annulus 90.

Alternatively, if the crown 14 does not already include leaflets,leaflets (not shown) may be attached to the crown 14 and/or the basemember 12, for example, as taught by Lane in U.S. Pat. No. 6,371,983,incorporated by reference above. In a further alternative, if the crown14 is an intermediate connector, a separate valve member (not shown) maybe introduced into the annulus 90 and attached to the crown and/or basemember, similar to the embodiments described above. For example, thecrown, the base member, and/or the valve member may include guides and/or cooperating connectors for orienting the valve member and/orattaching it to the crown and/or base member, as will be appreciated bythose skilled in the art.

Optionally, if it is desirable to remove all or part of the heart valveassembly 10, the crown 14 may be detached and/or removed (not shown)from the base member 12. For example, a tool (not shown) may beintroduced into the annulus 90 to depress the protrusions 24 ordisengage them (or any other cooperating connectors, not shown) from theapertures 34 to release the crown 14. The crown 14 may then beretrieved, e.g., using the holder 60 or other tool, and withdrawn fromthe annulus 90. Thus, the crown 14 and/or its leaflets or valve body maybe replaced, as needed. Optionally, the base member 12 may also beremoved by removing the fasteners securing the base member 12 to theannulus 90, as will be appreciated by those skilled in the art.

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. A heart valve assembly comprising: a base member generally defining aplane and comprising a multi-lobular annular shape within the plane; anannular body comprising a multi-lobular shape complementary to themulti-lobular shape of the base member; and cooperating connectors onthe base member and the annular body for connecting the annular body tothe base member.
 2. The assembly of claim 1, wherein the cooperatingconnectors comprise first and second connectors on the base member andthe annular body, respectively.
 3. The assembly of claim 2, wherein thefirst connector extends substantially continuously along a perimeter ofthe base member.
 4. The assembly of claim 2, wherein the first connectorcomprises a plurality of connector elements spaced apart along aperimeter of the base member.
 5. The assembly of claim 2, wherein one ofthe first and second connectors comprises a protrusion, and wherein theother of the first and second connectors comprises an aperture forreceiving the protrusion therein.
 6. The assembly of claim 5, whereinthe protrusion is resilient.
 7. The assembly of claim 5, wherein theaperture comprises at least one of a port, pocket, cavity, and hole. 8.The assembly of claim 1, wherein the base member comprises a rigid baseand a flexible cuff for attaching the base to a biological annulus. 9.The assembly of claim 1, wherein the annular body comprises a connectingmember for connecting a valve member to the base member.
 10. Theassembly of claim 1, wherein the annular body comprises a valve member.11. A heart valve assembly, comprising: a base member generally defininga plane and a longitudinal axis substantially orthogonal to the plane,the base member comprising a multi-lobular annular shape within theplane; an annular body comprising a multi-lobular shape complementary tothe multi-lobular shape of the base member, and guides on at least oneof the base member and the annular body for aligning the multi-lobularshapes with one another about the longitudinal axis.
 12. The assembly ofclaim 11, further comprising cooperating connectors on the base memberand the annular body for attaching the annular body to the base member.13. The assembly of claim 11, wherein the base member comprises a rigidbase and a flexible cuff for attaching the base to a biological annulus.14. The assembly of claim 11, wherein the annular body comprises aconnecting member for connecting a valve member to the base member. 15.The assembly of claim 11, wherein the annular body comprises a valvemember.
 16. The assembly of claim 11, wherein the guides comprise visualmarkers on the annular body and the base member that may aligned withinone another when the multi-lobular shape of the annular body is alignedwith the multi-lobular shape of the base member.
 17. The assembly ofclaim 11, wherein the guides comprise tactile markers on the annularbody and the base member that may interact with one another when themulti-lobular shape of the annular body is aligned with themulti-lobular shape of the base member.
 18. The assembly of claim 11,wherein the guides comprise one or more tethers extending from the basemember and through the annular body such that the annular body isslidable along the tethers to align the annular body with the basemember as the annular body is directed towards the base member.
 19. Theassembly of claim 18, wherein the one or more tethers comprise ratchetsspaced apart along a portion of the one or more tethers, therebyproviding at least one of a tactile indication and an audible indicationas the annular body is directed towards the base member.
 20. Theassembly of claim 19, wherein each of the tethers extends through aguide channel in the annular body, the ratchet elements engaging theguide channel to allow the annular body to be directed towards the baseelement but preventing the annular body from being directed away fromthe base member.
 21. The assembly of claim 18, wherein the one or moretethers are attached to the base member.
 22. The assembly of claim 21,wherein the one or more tethers are detachable from the base member. 23.A method for assembling a heart valve comprising a base membercomprising a multi-lobular annular shape and a second device comprisinga multi-lobular shape complementary to the multi-lobular shape of thebase member, the method comprising: moving the second device adjacent tothe base member, wherein the multi-lobular shape of the second devicealigns with the multi-lobular shape of the base member; and attachingthe second device to the base member.
 24. The method of claim 23,wherein moving the second device adjacent to the base member comprisessliding the second device along one or more guide members towards thebase member.
 25. The method of claim 23, wherein attaching the seconddevice to the base member comprises engaging cooperating connectors onthe second device and the base member.
 26. The method of claim 25,wherein the cooperating connectors comprise protrusions on at least oneof the second device and the base member that are received incorresponding apertures in the other of the second device and the basemember.
 27. The method of claim 23, wherein the second device comprisesa valve member.
 28. The method of claim 23, wherein the multi-lobularshape of the second device is aligned with the multi-lobular shape ofthe base member using guides on the second device and the base member.29. The method of claim 28, wherein the guides comprise at least one ofvisual markers and tactile markers.
 30. The method of claim 28, whereinthe guides comprise one or more tethers extending from the base member,the annular body sliding along the one or more tethers as the annularbody is moved adjacent the base member.
 31. A method for implanting aheart valve within a biological annulus within a heart of a patient,comprising: attaching a base member to the biological annulus, the basemember having a multi-lobular annular shape corresponding generally to across-section of the annulus; guiding a valve member comprising amulti-lobular shape complementary to the base member adjacent theannulus; orienting the valve member such that the multi-lobular shape ofthe valve member is aligned with the multi-lobular shape of the basemember; and attaching the valve member to the base member.
 32. Themethod of claim 31, wherein the base member comprises a flexible cuffextending from an anchoring ring, and wherein the flexible cuff isattached to the annulus to attach the base member to the annulus. 33.The method of claim 31, wherein the valve member is oriented using atleast one or visual markers and tactile markers on the valve member andthe base member.
 34. The method of claim 31, wherein the valve member isguided to the base member along one or more tethers extending from thebase member.
 35. The method of claim 34, wherein the valve membercomprises one or more guide channels through which the one or moretethers pass, the tethers and guide channels being arranged relative toone another to orient the valve member as the valve member is guided tothe base member.